As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Level: Mid
- Travel: Yes
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Success Profile
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
Join Our Growing Team of CMC Regulatory Professionals!
As we prepare for future growth, we are looking for Regulatory Affairs professionals with CMC experience to join a large, dedicated client FSP program.
Whether you’re a detail-oriented professional passionate about regulatory affairs and eager to contribute to successful document submissions, a seasoned Regulatory CMC professional with experience implementing CMC strategies for Biological and/or vaccines projects, we invite you to apply for this exciting opportunity on our team.
As a CMC Regulatory Affairs Associate, you will:
- Play a crucial part in coordinating various Global regulatory submissions ie. INDs, IMPDs, BLA/NDS/MAA post-approval commitments, Annual Reports, and Responses to regulatory authority questions.
- Assist in the preparation and coordination of global regulatory submissions, ensuring all submissions are complete, accurate, and compliant with regulatory requirements
- Manage submission timelines and coordinate with cross-functional teams to gather necessary documentation
- Support the team in conducting regulatory assessments of manufacturing changes, analyze the potential impact, and assist in preparing documentation to support manufacturing change assessments
- Facilitate effective communication between cross functional teams and regulatory authorities
- Participate and facilitate project team meetings to provide regulatory input and updates
- Maintain accurate and up-to-date regulatory documentation
Focus on global experience is extremely important.
Educational and Experience Requirements:
The CMC Regulatory Affairs career path offers opportunities for professionals with varying levels of education and experience:
- Associate: Bachelor's degree in a relevant field with 3+ years of experience
- Senior Associate: Advanced degree (Ph.D. preferred) with 7+ years of experience
- Consultant: Advanced degree (Ph.D. preferred) with 10+ years of experience
- Senior Consultant: Advanced degree (Ph.D. preferred) with 15+ years of experience
These requirements reflect an increasing complexity and responsibility of each role, from entry-level positions to senior leadership.
Ideal Candidate Profile:
We seek individuals who embody a unique blend of qualities essential for success in the dynamic field of CMC Regulatory Affairs:
- Technical Proficiency: Deep understanding of pharmaceutical development, manufacturing processes, and quality systems.
- Regulatory Expertise: Comprehensive knowledge of global CMC regulatory requirements and submission processes.
- Strategic Thinking: Ability to develop and implement innovative regulatory strategies aligned with business objectives.
- Leadership: Proven track record of guiding cross-functional teams and influencing decision-making at various organizational levels.
- Communication: Exceptional written and verbal skills for effective interaction with internal teams, external partners, and regulatory authorities.
- Adaptability: Flexibility to navigate evolving regulatory landscapes and shifting priorities.
- Problem-Solving: Strong analytical skills and innovative approaches to addressing complex regulatory challenges.
- Project Management: Capability to manage multiple complex projects simultaneously while maintaining attention to detail.
- Industry Passion: Genuine enthusiasm for contributing to successful product development and regulatory submissions in the pharmaceutical sector.
This role offer exciting opportunities for growth and impact within a collaborative and forward-thinking team environment. Ideal candidates will be motivated by the chance to shape regulatory strategies, drive successful submissions, and ultimately contribute to bringing important medical advancements to patients worldwide.
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